EN 13544-1

EN 13544-1:2007+A1:2009: Respiratory therapy equipment – Part 1: Nebulizing systems and their components

DIN EN 13544-1:2009-12 (E)
Respiratory therapy equipment – Part 1: Nebulizing systems and their components
(includes Amendment A1:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….5
Introduction ……………………………………………………………………………………………………………………………………6
1 R) Scope …………………………………………………………………………………………………………………………7
2 Normative references ……………………………………………………………………………………………………..7
3 Terms and definitions ……………………………………………………………………………………………………..9
4 General requirements and general requirements for test ………………………………………………..10
4.1 Modifications to Clause 3 of EN 60601-1:1990 ………………………………………………………………..10
4.2 Clause 4 of EN 60601-1:1990 ………………………………………………………………………………………….11
4.3 Alternative type-test methods ………………………………………………………………………………………..11
5 Classification ………………………………………………………………………………………………………………..11
6 Identification, marking and documents ………………………………………………………………………….11
6.1 Marking on the outside of equipment or equipment parts ………………………………………………11
6.3 Marking of controls and instruments ……………………………………………………………………………..12
6.4 Symbols ……………………………………………………………………………………………………………………….12
6.8.2 Instructions for use ……………………………………………………………………………………………………….12
6.8.3 Technical description ……………………………………………………………………………………………………14
7 Power input …………………………………………………………………………………………………………………..15
8 Basic safety categories …………………………………………………………………………………………………15
9 Removable protective means ………………………………………………………………………………………..15
10 Environmental conditions ……………………………………………………………………………………………..15
11 Not used ……………………………………………………………………………………………………………………….15
12 Not used ……………………………………………………………………………………………………………………….15
13 General …………………………………………………………………………………………………………………………15
14 Requirements related to classification …………………………………………………………………………..15
15 Limitation of voltage and/or energy ……………………………………………………………………………….16
16 Enclosures and protective covers ………………………………………………………………………………….16
17 Separation …………………………………………………………………………………………………………………….16
18 Protective earthing, functional earthing and potential equalization …………………………………16
19 Continuous leakage currents and patient auxiliary currents …………………………………………..16
20 Dielectric strength …………………………………………………………………………………………………………16

21 Mechanical strength …………………………………………………………………………………………………….. 16
22 Moving parts ……………………………………………………………………………………………………………….. 16
23 Surfaces, corners and edges ……………………………………………………………………………………….. 16
24 Stability in normal use …………………………………………………………………………………………………. 17
25 Expelled parts ……………………………………………………………………………………………………………… 17
26 Vibration and noise ……………………………………………………………………………………………………… 17
27 Pneumatic and hydraulic power …………………………………………………………………………………… 17
28 Suspended masses ……………………………………………………………………………………………………… 17
29 X-radiation …………………………………………………………………………………………………………………… 17
30 Alpha, beta, gamma, neutron radiation and other particle radiation ………………………………. 17
31 Microwave radiation …………………………………………………………………………………………………….. 18
32 Light radiation (including lasers) ………………………………………………………………………………….. 18
33 Infra-red radiation ………………………………………………………………………………………………………… 18
34 Ultra-violet radiation …………………………………………………………………………………………………….. 18
35 Acoustical energy (including ultra-sonics) ……………………………………………………………………. 18
36 Electromagnetic compatibility ……………………………………………………………………………………… 18
37 R) Locations and basic requirements …………………………………………………………………………… 18
38 R) Marking, accompanying documents ………………………………………………………………………… 18
39 R) Common requirements for category AP and category APG equipment ……………………… 18
40 R) Requirements and tests for Category AP equipment, parts and components thereof … 19
41 R) Requirements and tests for Category APG equipment, parts and components thereof 19
42 Excessive temperatures ………………………………………………………………………………………………. 19
43 R) Fire prevention ………………………………………………………………………………………………………… 19
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection ………………………………………………………………………………………………………………….. 19
45 Pressure vessels and parts subject to pressure ……………………………………………………………. 20
46 Human errors ………………………………………………………………………………………………………………. 20
47 Electrostatic charges …………………………………………………………………………………………………… 20
48 Biocompatibility …………………………………………………………………………………………………………… 20
49 Interruption of the power supply ………………………………………………………………………………….. 20
50 Accuracy of operating data ………………………………………………………………………………………….. 20

51 Protection against hazardous output ……………………………………………………………………………..21
52 Abnormal operation and fault conditions ……………………………………………………………………….21
53 Environmental tests ………………………………………………………………………………………………………21
54 General …………………………………………………………………………………………………………………………21
55 Enclosures and covers ………………………………………………………………………………………………….22
56 Components and general assembly ……………………………………………………………………………….22
57 Mains parts, components and layout ……………………………………………………………………………..23
58 Protective earthing – Terminals and connections ……………………………………………………………23
59 Construction and layout ………………………………………………………………………………………………..23
Annex A A (informative) Rationale ………………………………………………………………………………………………..24
Annex B B (informative) Diameters of the particles depositable fraction ………………………………………..27
Annex C C (normative) Test methods for the aerosol output rate, the aerosol output and for
particle sizing ……………………………………………………………………………………………………………….28
CC.1 Method of test for the aerosol output rate ……………………………………………………………………………..28
CC.1.1 Test conditions ………………………………………………………………………………………………………………….28
CC.1.2 R) Principle of test ……………………………………………………………………………………………………………..28
CC.1.3 Test equipment ………………………………………………………………………………………………………………….28
Annex D D (normative) Mass balance checks on cascade impactor tests ………………………………………36
DD.1 Aerosol output rate and aerosol output tests: ……………………………………………………………………….36
DD.2 Particle sizing test ………………………………………………………………………………………………………………..36
Annex E E (informative) Environmental aspects ……………………………………………………………………………37
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC on medical devices …………………………………………39
Bibliography …………………………………………………………………………………………………………………………………43